Trial Cleared for Lab-Grown Replacement Knee Cartilage

Knee joint X-ray (AKha, Wikimedia Commons)

25 July 2023. A biotechnology company creating living tissue from a person’s stem cells says it received FDA clearance for a clinical trial of its replacement knee cartilage. EpiBone Inc. in Jersey City, New Jersey — a spin-off enterprise from biomedical engineering labs at Columbia University — expects the study to begin in early 2024.

EpiBone says its process creates cartilage grafts for people needing new knee cartilage from sports injuries or other trauma, and arthritis resulting from knee trauma. The company says current tissue engineering techniques use cartilage samples from deceased donors, which while effective, can help a relatively few patients due to donation shortages. EpiBone says its technology that uses stem cells from patients to seed and cultivate replacement tissue, reduces risks of possible disease transmission or mismatched tissue from donors.

That technology, says EpiBone, starts with a precisely measured, personalized scaffold infused with stem cells in this case from bone marrow. The scaffold with stem cells are placed in a bioreactor, where the stem cells transform into cartilage cells, then multiply into new tissue forming around the scaffold. The bioreactor provides nourishment and controls the environment for stem cells to differentiate or mature into working tissue. When fully formed, the new cartilage can then be surgically implanted in the patient.

Better integration with surrounding tissue

The company released results of a preclinical study with horses conducted by Cornell University and reported in April 2023 at a meeting of the International Cartilage Regeneration and Joint Preservation Society in Nice, France. The study compared lab-grown cartilage tissue from the animals’ bone marrow stem cells to cartilage produced from donated cadaver tissue. The findings, says lead investigator and Cornell veterinary medicine professor Lisa Fortier, show similar performance results, but the lab-grown cartilage integrates better with surrounding tissue.

EpiBone co-founder and CEO Nina Tandon expects the company’s cartilage technology to first benefit younger people with sports injuries, “who need their knees to function for many years to come.” Tandon notes in a company statement released through Cision, “With this lab-grown living cartilage, we are able to offer patients a new avenue to harness the power of living cells to help cartilage heal when it normally is notoriously slow to recover from injury, if it recovers at all.”

According to EpiBone, the Food and Drug Administration cleared the company’s investigational new drug application or IND, in effect authorizing EpiBone to begin a clinical trial of its lab-grown cartilage. No further details of that clinical trial are yet disclosed. The company’s lead product, engineered bone tissue produced from a patient’s adipose or fat stem cells for facial reconstruction, is in an early- and mid-stage clinical trial.

Science & Enterprise reported in June 2016 on publication of preclinical findings showing the feasibility of lab-grown facial bone tissue from stem cells that precisely fits the defects and after six months integrates with host facial bones. The study was led by Gordana Vunjak-Novakovic, biomedical engineering professor at Columbia University and a co-founder of EpiBone with Tandon and first author Sarindr Bhumiratana, now the company’s chief scientist.

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